Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Senior Director, Regulatory Affairs - Regulatory Team Lead-144227

Company: PPD
Location: Europe, Middle East & Africa-UK-England-Cambridge,
Reference: 144227
Closing Date: 20 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Senior Director, Regulatory Affairs – Regulatory LeadPPD has an exciting new vacancy for a Senior Director within the Regulatory Affairs Department.  This is a key leadership role in which you will have the opportunity to leverage your breadth of experience together with your proven strategic and leadership background, and take your Regulatory Affairs career to the next level. ...

Requirements:

Senior Director, Regulatory Affairs – Regulatory Lead

PPD has an exciting new vacancy for a Senior Director within the Regulatory Affairs Department.  This is a key leadership role in which you will have the opportunity to leverage your breadth of experience together with your proven strategic and leadership background, and take your Regulatory Affairs career to the next level.

The purpose of this role is to oversee operational excellence for the department, developing strategies to ensure a quality product to the customer. Provides advice and strategic guidance to staff ensuring all aspects of regulatory activities comply with the sponsor, company and regulatory requirements. Direct the business strategy focusing on innovation, operational efficiency and expansion of the department's global footprint. Provide overall leadership to a strong and dynamic team, and growing business unit.  

In this role, you will:
•    Line manage a team of 5-6 senior level staff, which may be located across multiple regions.
•    Direct the business strategy for the department, focusing on technical capabilities and innovation. Serves as liaison to executive management, and liaise with internal functional teams and clients.
•    Provide regulatory consulting and strategic advice to internal and external clients
•    Provide project specific strategy, technical expertise and coordination oversight for key client’s projects.
•    Serves as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions.
•    Oversee project budgeting/forecasting
•    Collaborate with business development and senior management in pricing and securing new business by making presentations to clients, developing and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD.
•    Establish policies appropriate for the function. Interprets and recommends modifications to company-wide policies and practices. Develops and is responsible for budgets, schedules, and performance standards.
•    Interact with senior management, and others concerning matters of significance to the company. Conducts business and technical briefings for senior and top management and for external management and / or representatives.

 

Qualifications

Education and Experience: 

•    Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
•    Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15 years’)
•    Advanced leadership skills and line management experience
•    Expertise with ATMP/Gene Therapy, Medical Devices, or Vaccines would be advantageous
•    CRO/Consulting and customer facing experience is desirable
•    Strong regulatory strategy background and full understand of end to end drug development process.



Knowledge, Skills and Abilities:
•    Proven experience in business development activities and networking
•    Superior English language communication and negotiation skills, as well as local language where applicable
•    Excellent understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and life-cycle management; superior understanding of ICH and other global regulatory guidelines; advanced knowledge of at least one of the regulatory specialty areas: preclinical, clinical, CMC, publishing, etc.
•    Advanced understanding of budgeting and forecasting with the ability to interpret data with attention to detail
•    Capable of supervising, evaluating, and mentoring departmental personnel
•    Capable of driving innovation in developing new ideas related to process improvements
•    Excellent organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities
•    Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
•    Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
•    Capable of independently learning new technologies
•    Outstanding analytical skills to work on extremely complex problems where analysis of situations or data requires and evaluation of intangible variables
•    Capable of effectively acting as a liaison with other departments

Apply for this job: Senior Director, Regulatory Affairs - Regulatory Team Lead-144227

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.